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U.S. Department of Health and Human Services

About FDA

Percent of Office of Device Evaluation (ODE) 180-Day PMA Supplements decisions made in 180 days or less during the quarter

Dictionary: Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).

A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report. The measure tracks the number of 180-day PMA Supplements decisions made during the quarter that were within 180 FDA days. It includes only fee-paying 180-day PMA supplements.

Information is current as of September 30, 2013

Fiscal Year - 2011

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TimeTargetPercent
Oct – Dec 20108067
Jan – Mar 20118084
Apr – Jun 20118091
Jul – Sep 20118096

FY 2011 Overall: 83%

Number of ODE 180-Day PMA Supplements decisions made in 180 days or less during the quarter

Fiscal Year - 2011
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TimeTargetNumber
Oct – Dec 2010N/A33
Jan – Mar 2011N/A16
Apr – Jun 2011N/A51
Jul – Sep 2011N/A24

FY 2011 Total: 124

Total number of ODE 180-Day PMA Supplements decisions made during the quarter

Fiscal Year - 2011
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TimeTargetNumber
Oct – Dec 2010N/A49
Jan – Mar 2011N/A19
Apr – Jun 2011N/A56
Jul – Sep 2011N/A25

FY 2011 Total: 149

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.